Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access; Public Workshop; Request for Comments, 46065-46066 [2017-21186]
Download as PDF
46065
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
Average
time per
response
(in hours)
Total
burden
hours
(annual)
Type of
respondent
Form name
Estimated number of
respondents
Number of responses
per respondent
Project staff ...............................
Local agency leaders ................
Semi-annual Performance Report .....................
Program Information Cover Sheet/Participant
Information Form/Attendance Log/Post Program Survey.
18 ................................
700 leaders .................
Twice a year .............................
Twice a year (one set per program).
8
.50
288
700
46 data entry staff ......
.50
700
.05
35
Local data entry staff ................
Local organization staff and
local database entry staff.
Program participants .................
Program participants .................
Host Organization Data Form ...........................
700 staff ......................
Once per program x 1400 programs.
1 ...............................................
Participant Information Form .............................
Post Program Survey ........................................
16,390 .........................
983 ..............................
1 ...............................................
1 ...............................................
.10
.10
1,639
983
Total Burden Hours ...........
............................................................................
.....................................
...................................................
................
4,345
Dated: September 20, 2017.
Mary Lazare,
Principal Deputy Administrator.
[FR Doc. 2017–21179 Filed 10–2–17; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5437]
Topical Dermatological Generic Drug
Products: Overcoming Barriers to
Development and Improving Patient
Access; Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Topical
Dermatological Generic Drug Products:
Overcoming Barriers to Development
and Improving Patient Access.’’ The
purpose of the public workshop is to
provide an overview of current
regulatory science initiatives related to
generic topical dermatological drug
products, solicit public input on
scientific barriers that may limit patient
access to such drug products, and
discuss approaches to overcome/address
any such barriers. FDA is seeking public
input from a variety of stakeholders,
including industry, academia, patient
advocates, and professional
associations.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
The public workshop will be
held on October 20, 2017, from 8:30
a.m. to 4:30 p.m., Eastern Standard
Time. Submit either electronic or
written comments on this public
workshop by November 20, 2017. See
the SUPPLEMENTARY INFORMATION section
for registration date and information.
DATES:
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
The public workshop will
be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503A), Silver Spring, MD 20993–0002.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/Workingat
FDA/BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before November 20, 2017. The
https://www.regulations.gov electronic
filing system will accept comments
until midnight Eastern Time at the end
of November 20, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–5437 for ‘‘Topical
Dermatological Generic Drug Products:
Overcoming Barriers to Development
and Improving Patient Access.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
E:\FR\FM\03OCN1.SGM
03OCN1
46066
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
asabaliauskas on DSKBBXCHB2PROD with NOTICES
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sam
Raney, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 4706, Silver Spring,
MD 20993, 240–402–7967, email:
Sameersingh.Raney@fda.hhs.gov; or
Markham Luke, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4712,
Silver Spring, MD 20993, 301–796–
5556, email: Markham.Luke@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The conventional approach to
establish bioequivalence (BE) for most
topical dermatological generic drug
products relies upon clinical endpoint
BE studies. The risk of failing to
demonstrate BE due to the relative
insensitivity of these clinical endpoint
studies, combined with their burden
and length, may represent a barrier to
generic drug development and may
adversely impact patient access to some
topical dermatological generic drug
products. FDA is evaluating alternative
BE approaches for topical
dermatological generic drug products,
using methods that are more efficient,
and also more sensitive and
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
reproducible. FDA believes that these
BE approaches would benefit from
public discussion.
II. Topics for Discussion at the Public
Workshop
This public workshop will focus on a
discussion of current regulatory science
initiatives intended to foster the
development of topical dermatological
generic drug products, examining
alternative BE approaches that may be
more efficient and less risky than
traditional approaches. FDA is also
interested in receiving public input
about any barriers that may limit the use
of such alternative BE approaches in the
development of topical dermatological
generic drug products. Public input is
also sought about strategies to overcome
these barriers.
III. Participating in the Public
Workshop
Registration: Persons interested in
attending this public workshop must
register online at https://
survey.co1.qualtrics.com/jfe/form/SV_
9YQDLZJRjXtYiXz. Please provide
complete contact information for each
attendee, including name, title,
affiliation, address, email, and
telephone.
Registration is free and based on
space availability, with priority given to
early registrants. Persons interested in
attending this public workshop must
register by October 13, 2017, midnight,
Eastern Time. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization.
If you need special accommodations
due to a disability, please contact Sam
Raney (see FOR FURTHER INFORMATION
CONTACT) no later than October 13, 2017.
Requests for Oral Presentations:
During online registration you may
indicate if you wish to present during a
public comment session, and which
topic(s) you wish to address. We will do
our best to accommodate requests to
make public comments. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations, and to request time for a
joint presentation, or to submit requests
for designated representatives to
participate in the focused sessions.
Following the close of registration, we
will determine the amount of time
allotted to each presenter and the
approximate time each oral presentation
is to begin, and will select and notify
participants by October 16, 2017. All
requests to make oral presentations
must be received by the close of
registration on October 9, 2017. If
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
selected for presentation, any
presentation materials must be emailed
to GDUFARegulatoryScience@
fda.hhs.gov no later than October 13,
2017. No commercial or promotional
material will be permitted to be
presented or distributed at the public
workshop.
Streaming webcast of the public
workshop: This public workshop will
also be webcast. A live webcast of this
workshop will be viewable at https://
collaboration.fda.gov/ogddermaldrug/
on the day of the workshop.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that as
soon as a transcript of the public
workshop is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Dockets Management Staff (see
ADDRESSES). A link to the transcript will
also be available on the internet at
https://www.fda.gov/Drugs/NewsEvents/
ucm557252.htm.
Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21186 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–5670]
Abbreviated New Drug Applications
Submissions—Amendments To
Abbreviated New Drug Applications
Under the Generic Drug User Fee Act;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘ANDA
Submissions—Amendments to
Abbreviated New Drug Applications
Under GDUFA.’’ This draft guidance is
intended to explain to applicants how
SUMMARY:
E:\FR\FM\03OCN1.SGM
03OCN1
Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46065-46066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21186]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-5437]
Topical Dermatological Generic Drug Products: Overcoming Barriers
to Development and Improving Patient Access; Public Workshop; Request
for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public workshop entitled ``Topical
Dermatological Generic Drug Products: Overcoming Barriers to
Development and Improving Patient Access.'' The purpose of the public
workshop is to provide an overview of current regulatory science
initiatives related to generic topical dermatological drug products,
solicit public input on scientific barriers that may limit patient
access to such drug products, and discuss approaches to overcome/
address any such barriers. FDA is seeking public input from a variety
of stakeholders, including industry, academia, patient advocates, and
professional associations.
DATES: The public workshop will be held on October 20, 2017, from 8:30
a.m. to 4:30 p.m., Eastern Standard Time. Submit either electronic or
written comments on this public workshop by November 20, 2017. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 20, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 20, 2017. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-5437 for ``Topical Dermatological Generic Drug Products:
Overcoming Barriers to Development and Improving Patient Access.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
[[Page 46066]]
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Sam Raney, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 75, Rm. 4706, Silver Spring, MD 20993, 240-402-7967, email:
Sameersingh.Raney@fda.hhs.gov; or Markham Luke, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4712, Silver Spring, MD 20993, 301-796-
5556, email: Markham.Luke@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The conventional approach to establish bioequivalence (BE) for most
topical dermatological generic drug products relies upon clinical
endpoint BE studies. The risk of failing to demonstrate BE due to the
relative insensitivity of these clinical endpoint studies, combined
with their burden and length, may represent a barrier to generic drug
development and may adversely impact patient access to some topical
dermatological generic drug products. FDA is evaluating alternative BE
approaches for topical dermatological generic drug products, using
methods that are more efficient, and also more sensitive and
reproducible. FDA believes that these BE approaches would benefit from
public discussion.
II. Topics for Discussion at the Public Workshop
This public workshop will focus on a discussion of current
regulatory science initiatives intended to foster the development of
topical dermatological generic drug products, examining alternative BE
approaches that may be more efficient and less risky than traditional
approaches. FDA is also interested in receiving public input about any
barriers that may limit the use of such alternative BE approaches in
the development of topical dermatological generic drug products. Public
input is also sought about strategies to overcome these barriers.
III. Participating in the Public Workshop
Registration: Persons interested in attending this public workshop
must register online at https://survey.co1.qualtrics.com/jfe/form/SV_9YQDLZJRjXtYiXz. Please provide complete contact information for
each attendee, including name, title, affiliation, address, email, and
telephone.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by October 13, 2017, midnight, Eastern Time.
Early registration is recommended because seating is limited;
therefore, FDA may limit the number of participants from each
organization.
If you need special accommodations due to a disability, please
contact Sam Raney (see FOR FURTHER INFORMATION CONTACT) no later than
October 13, 2017.
Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session, and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and to request time for a joint presentation, or to
submit requests for designated representatives to participate in the
focused sessions. Following the close of registration, we will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by October 16, 2017. All requests to make oral
presentations must be received by the close of registration on October
9, 2017. If selected for presentation, any presentation materials must
be emailed to GDUFARegulatoryScience@fda.hhs.gov no later than October
13, 2017. No commercial or promotional material will be permitted to be
presented or distributed at the public workshop.
Streaming webcast of the public workshop: This public workshop will
also be webcast. A live webcast of this workshop will be viewable at
https://collaboration.fda.gov/ogddermaldrug/ on the day of the
workshop.
If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the Web site addresses in this document, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm557252.htm.
Dated: September 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21186 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P